NCT00002297

Brief Summary

The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include: Signs and symptoms:

  • Lymphadenopathy.
  • Fever.
  • Weight loss.
  • Occurrence of opportunistic infections. Cell-mediated immune system parameters:
  • T-helper cell (OKT4) numbers and proportions.
  • T-suppressor cell (OKT8) numbers and proportions.
  • Natural killer (NK) cell activity.
  • Lymphocyte blastogenic response to phytohemagglutinin (PHA).
  • Lymphocyte blastogenic response to pokeweed mitogen (PWM).
  • Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
  • Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora. Safety parameters:
  • Blood chemistry including serum uric acid (PurposeA-12).
  • Complete blood count (CBC).
  • Platelet count.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Lymphatic DiseaseHIV Infections

Keywords

Inosine PranobexAIDS-Related Complex

Interventions

Inosine pranobexDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Co-existing Condition:
  • Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.
  • Concurrent Medication:
  • Excluded:
  • Systemic corticosteroids.
  • Cytotoxic immunosuppressive agents.
  • Radiotherapy.
  • Critically ill patients or those with CDC-defined AIDS are excluded.
  • Prior Medication:
  • Excluded within 1 month of study entry:
  • Immunotherapy.
  • Patients with persistent generalized lymphadenopathy (PGL).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newport Pharmaceuticals International Inc

Laguna Hills, California, 92656, United States

Location

MeSH Terms

Conditions

Lymphatic DiseasesHIV InfectionsAIDS-Related Complex

Interventions

Inosine Pranobex

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1989-06

Locations

US(1)